How to screw up a clinical trial

  • Amarin’s clinical trial of fish oil may be tainted because of suspicions that the placebo group received mineral oil which could affect the absorption of statins. This “anti-statin” effect could raise “bad cholesterol” levels, enhancing the separation of major adverse cardiac events (MACE) between Vascepa and control.
  • Cardiologists who reviewed the data see a big problem with the study that could mean that it exaggerates Vascepa’s benefits.
  • Mineral oil may not not behaved as a placebo at all.
  • Will insurers recommend OTC fish oil?

Amarin may have to spend a LOT of money for another clinical trial for their fish oil supplement according to an article in Forbes.  The questions from cardiologists on Vascepa’s benefits go deep and insurers may not be so willing to cover a product which can easily be purchased OTC.

Fish Oil or Snake oil?

According to the JAMA network “more people than ever take fish oil dietary supplements—around 8% of US adults in 2012 compared with around 5% five years earlier, according to the National Center for Health Statistics. But a recent meta-analysis of 10 large clinical trials came to a disappointing conclusion: The popular capsules do little to protect patients with heart disease. The findings are at odds with advice from the American Heart Association (AHA), including a 2017 science advisory recommendation to consider fish oil supplementation for patients with a recent myocardial infarction, or heart attack”.

Then there is this conclusion from the NEJM “Supplementation with n−3 fatty acids did not result in a lower incidence of major cardiovascular events or cancer than placebo. (Funded by the National Institutes of Health and others; VITAL ClinicalTrials.gov number, NCT01169259.)

Prescription Medications versus OTC Meds

Consumers, despite all the bad news around fish oil, may rather decide to purchase OTC medications instead as they trust OTC products more than prescription drugs. Here are some stats around OTC products.

  • There are a total of 2.9 billion retail trips annually to purchase OTC products. (source: IRI, 2015)
  • On average, U.S. households spend about $338 per year on OTC products. (source: IRI, 2015)
  • U.S. consumers make 26 trips a year to purchase OTC products. They only visit doctors, on average, three times a year.
  • OTC medicines provide AFFORDABLE treatment options for both consumers and the U.S. healthcare system.
  • The availability of OTC medicines creates significant value for the U.S. healthcare system: $102 billion in annual savings relative to alternatives.
    $77 billion in clinical cost savings (avoided doctor’s office visits and diagnostic testing); and $25 billion in drug cost savings (lower priced OTCs versus higher priced prescription medicines).
  • For a range of illnesses, 8 in 10 consumers use OTC medicines to relieve their symptoms without having to see a healthcare professional.
  • 92 percent of physicians believe OTC medicines are effective, and 91 percent believe these medicines are safe.
  • 87 percent of physicians believe OTC medicines are an important part of overall healthcare.
  • 89 percent of consumers believe OTC medicines are an important part of their overall family healthcare.

It’s hard to understand how Amarin could screw up a clinical trial that results in more questions than answers.  Right now consumers are confused on the viability of fish oil and it’s up to each person to determine of fish oil is a helpful product or just a “feel good” product.

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